Eclipse Blood Collection Set

Tubes, Vials, Systems, Serum Separators, Blood Collection

Eclipse Medcorp LLC

The following data is part of a premarket notification filed by Eclipse Medcorp Llc with the FDA for Eclipse Blood Collection Set.

Pre-market Notification Details

Device IDK213690
510k NumberK213690
Device Name:Eclipse Blood Collection Set
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Eclipse Medcorp LLC 5916 Stone Creek Drive Suite #120 The Colony,  TX  75056
ContactJulie Summerville
CorrespondentJulie Summerville
Eclipse Medcorp LLC 5916 Stone Creek Drive Suite #120 The Colony,  TX  75056
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-23
Decision Date2022-10-26

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